Biofortified orange maize is as efficacious as a vitamin A supplement in Zambian children even in the presence of high liver reserves of vitamin A: a community-based, randomized placebo-controlled trial.
Biofortified orange maize is as efficacious as a vitamin A supplement in Zambian children even in the presence of high liver reserves of vitamin A: a community-based, randomized placebo-controlled trial.
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DOI：
10.3945/ajcn.114.087379
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发表时间：
2014-12
期刊：
影响因子：
--
通讯作者：
Tanumihardjo SA
中科院分区：
文献类型：
--
作者：
Gannon B;Kaliwile C;Arscott SA;Schmaelzle S;Chileshe J;Kalungwana N;Mosonda M;Pixley K;Masi C;Tanumihardjo SA
背景：生物强化是缓解维生素A（VA）缺乏的一种策略。生物强化玉米含有增强的维生素A原浓度，在动物和小型人类研究中具有生物有效性。目的：本研究旨在确定维生素A的总身体储备（TBRs）与生物强化玉米消费的变化。设计：在140名赞比亚农村儿童中进行了一项随机、安慰剂对照的生物强化玉米疗效试验。配对13 C-视黄醇同位素稀释试验，VA状态的敏感生物标志物，被用来测量TBRs之前和之后的90天的干预。处理为白色玉米加安慰剂油（VA-）、橙子玉米加安慰剂（橙子）和白色玉米加VA油[400 μg视黄醇活性当量（RAE），每日214 μL]（VA+）。结果：总共有133名儿童完成了试验，并进行了TBRs分析（n = 44或45/组）。TBR残差的变化不呈正态分布（P < 0.0001）;中位变化（95% CI）如下：VA−，13（−19，44）μmol;橙子，84（21，146）μmol; VA+，98（24，171）μmol。非参数分析显示VA+和橙子之间无统计学差异（P = 0.34）;两者均高于VA-（P = 0.0034）。基线时计算的肝脏储备中位数（95%CI）为1.04（0.97，1.12）μmol/g肝脏，59% >1 μmol/g（亚毒性临界值）;没有人<0.1 μmol/g（缺乏临界值）。通过使用每组TBRs变化的中间3个五分位数计算的生物转化因子为10.4 μg β-胡萝卜素当量/1 μg视黄醇。血清视黄醇对干预没有反应（P = 0.16），但在基线时随着C反应蛋白（P = 0.0029）和α-1-酸性糖蛋白（P = 0.0023）升高而降低。结论：玉米中的β-胡萝卜素在该人群中作为主食食用时是有效的，并且可以避免使用来自补充和强化的预制VA观察到的维生素A过多症的可能性。需要使用比单独使用血清视黄醇更敏感的方法，如同位素稀释法，以准确评估VA状态，评价干预措施，并研究VA状态和感染的相互作用。本试验在clinicaltrials.gov上注册为NCT 01814891。
Background: Biofortification is a strategy to relieve vitamin A (VA) deficiency. Biofortified maize contains enhanced provitamin A concentrations and has been bioefficacious in animal and small human studies. Objective: The study sought to determine changes in total body reserves (TBRs) of vitamin A with consumption of biofortified maize. Design: A randomized, placebo-controlled biofortified maize efficacy trial was conducted in 140 rural Zambian children. The paired 13C-retinol isotope dilution test, a sensitive biomarker for VA status, was used to measure TBRs before and after a 90-d intervention. Treatments were white maize with placebo oil (VA−), orange maize with placebo (orange), and white maize with VA in oil [400 μg retinol activity equivalents (RAEs) in 214 μL daily] (VA+). Results: In total, 133 children completed the trial and were analyzed for TBRs (n = 44 or 45/group). Change in TBR residuals were not normally distributed (P < 0.0001); median changes (95% CI) were as follows: VA−, 13 (−19, 44) μmol; orange, 84 (21, 146) μmol; and VA+, 98 (24, 171) μmol. Nonparametric analysis showed no statistical difference between VA+ and orange (P = 0.34); both were higher than VA− (P = 0.0034). Median (95% CI) calculated liver reserves at baseline were 1.04 (0.97, 1.12) μmol/g liver, with 59% >1 μmol/g, the subtoxicity cutoff; none were <0.1 μmol/g, the deficiency cutoff. The calculated bioconversion factor was 10.4 μg β-carotene equivalents/1 μg retinol by using the middle 3 quintiles of change in TBRs from each group. Serum retinol did not change in response to intervention (P = 0.16) but was reduced with elevated C-reactive protein (P = 0.0029) and α-1-acid glycoprotein (P = 0.0023) at baseline. Conclusions: β-Carotene from maize was efficacious when consumed as a staple food in this population and could avoid the potential for hypervitaminosis A that was observed with the use of preformed VA from supplementation and fortification. Use of more sensitive methods other than serum retinol alone, such as isotope dilution, is required to accurately assess VA status, evaluate interventions, and investigate the interaction of VA status and infection. This trial was registered at clinicaltrials.gov as NCT01814891.
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